© 2006 Diabetes UK. Diabetic Medicine, 23, 341– 347 341 Abstract Aim To undertake a systematic review of the diagnostic performance of clinical examination, sample acquisition and sample analysis in infected foot ulcers in diabetes. Methods Nineteen electronic databases plus other sources were searched. To be included, studies had to fulfil the following criteria: (i) compare a method of clinical assessment, sample collection or sample analysis with a reference standard; (ii) recruit diabetic individuals with foot ulcers; (ii) present 2 × 2 diagnostic data. Studies were critically appraised using a 12-item checklist. Results Three eligible studies were identified, one each on clinical examination, sample collection and sample analysis. For all three, study groups were hetero- geneous with respect to wound type and a small proportion of participants had foot ulcers due to diabetes. No studies identified an optimum reference standard. Other methodological problems included non-blind interpretation of tests and the time lag between index and reference tests. Individual signs or symptoms of infection did not prove to be useful tests when assessed against punch biopsy as the reference standard. The wound swab did not perform well when assessed against tissue biopsy. Semiquantitative analysis of wound swab might be a useful alternative to quantitative analysis. The limitations of these findings and their impact on recommendations from relevant clinical guidelines are discussed. Conclusion Given the importance of this topic, it is surprising that only three eligible studies were identified. It was not possible to describe the optimal methods of diagnosing infection in diabetic patients with foot ulceration from the evidence identified in this systematic review. Diabet. Med. 23, 341–347 (2006) Keywords diabetic foot ulcer, diagnosis, infection, systematic review Abbreviations CFU, colony-forming unit; PCR, polymerase chain reaction; QUADAS, Quality Assessment tool for Diagnostic Accuracy Studies; ROC, receiver–operating characteristic Blackwell Publishing Ltd Oxford, UK DME Diabetic Medicine 0742-3071 Blackwell Publishing, 2006 23 Review Article Review article Review of methods to diagnose infection in diabetic foot ulcers S. O’Meara et al. Systematic review of methods to diagnose infection in foot ulcers in diabetes S. O’Meara, E. A. Nelson, S. Golder*, J. E. Dalton, D. Craig*, C. Iglesias on behalf of the DASIDU Steering Group (see footnote for members) Department of Health Sciences and *Centre for Reviews and Dissemination, University of York, York, UK Accepted 3 October 2005 Members of the DASIDU (Decision Analysis for Sampling and managing Infected Diabetic Ulcers) Steering Group: Dr E. Andrea Nelson, Susan O’Meara, Cynthia Iglesias, Sally EM Bell-Syer, Dr Karl Claxton*, Professor Andrew Boulton†, Dr Edward Jude†, Professor Christopher Dowson‡, Dr Roger Gadsby§, Mr Daniel Higman¶, Dr Paul O’Hare** and Professor Janet Powell†† (Department of Health Sciences, University of York, UK, *Department of Economics and Related Studies, University of York, UK, †Department of Diabetic Medicine, Manchester Royal Infirmary, UK, ‡Department of Biological Sciences, University of Warwick, UK, §Department of Primary Care, University of Warwick, UK, ¶Departments of General and Vascular Surgery, University Hospitals of Coventry and Warwickshire, UK, **Department of General Medicine, University Hospitals of Coventry and Warwickshire, UK, ††Department of Pathology, University Hospitals of Coventry and Warwickshire, UK). Correspondence to: S. O’Meara, Department of Health Sciences, University of York, Seebohm Rowntree Building (Area 3), York YO10 5 DD, UK. E-mail: smo4@york.ac.uk